Health Care Evaluation, Health Care Quality
Conditions
Keywords
Chronic myeloid leukemia, imatinib, interferon
Brief summary
Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly. Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months
Detailed description
130 patients registered, 112 randomized. 56 pats in each treatment arm. 12 months study duration. Rate of Major Molecular Response was at 12 months 53 vs 82 % (p=0.002) in favour of the combination arm.
Interventions
DRUGimatinib and pegylated interferon
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly
Sponsors
Uppsala University Hospital
Karolinska University Hospital
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG \< 2
Exclusion criteria
Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG \> 2 Pregnancy \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of rate Major Molecular Response between treatment arms | 2004 - 2009 | Molecular response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of complete cytogenetic response between the treatment arms at 12 months | 2004 - 2009 | Cytogenetic response |
| Comparison rate complete cytogenetic response between the treatment arms at 12 months | 2004 - 2009 | Hematologic response |
Countries
Sweden
Outcome results
None listed